A Phase I Study of Oxaliplatin in Combination With Gemcitabine

Trial Information

A Phase I Study of Oxaliplatin in Combination With Gemcitabine

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of
gemcitabine in combination with oxaliplatin in patients with advanced malignancies. II.
Determine the pharmacokinetics of oxaliplatin and gemcitabine in these patients.

OUTLINE: This is a multicenter, dose escalation study of gemcitabine. Patients receive
oxaliplatin IV over 2 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Treatment continues every 3 weeks in the absence of disease progression or unacceptable
toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination
with a fixed dose of oxaliplatin until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting
toxicity.

PROJECTED ACCRUAL: A total of 24-36 patients will be accrued for this study within 2 years.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic or unresectable malignancy for
which standard therapy does not exist or is no longer effective No greater than 3 prior
treatment regimens No known brain metastases

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